New Rx Rules: Concerns About Unintended Consequences

The Board of Registration in Pharmacy’s much anticipated regulations on how a pharmacy can conduct sterile compounding pose potential unintended consequences that could increase costs and disrupt patient care, according to comments from MHA and Massachusetts Society of Health-System Pharmacists (MSHP).

The board approved the regulations last Thursday and much of the new rule reflects input offered by MHA and MSHP members. But of great concern, according to the two associations, the proposed Massachusetts rules go far beyond the national evidence-based, expert consensus driven standards within Untied States Pharmacopeia Chapter 797.

Four areas relating to the pharmacy’s physical structure, environmental monitoring, personnel expansion and training, and increased reporting could result in “exorbitant investments, for some hospitals in the millions of dollars, just to meet compliance in facility structure and the hiring of additional staff to comply with monitoring and reporting requirements that will not improve sterile compounding practices,” MHA and MSHP wrote. The two groups asked the board to amend the regulation further to make it conform closer to the existing national standard in USP 797.